MAUDE Adverse Event Report: ZIMMER INC NEXGEN PATELLA REAMER BLADE; HTO

Catalog Number 00597909535

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual examination of the returned patella reamer blade revealed scuff marks and gouges on the blade.The 1.4290 product identifier dimension was measured and confirmed to be within tolerance.The device was used for treatment a complaint search based on the product and lot combination did not reveal any related complaints.The root cause cannot be determined.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.

Event Description

It was reported that the reamer blade was binding in the 35mm reamer guide.The blade was changed and surgery continued.

• Brand Name: NEXGEN PATELLA REAMER BLADE
• Type of Device: HTO
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5568675
• MDR Text Key: 42959855
• Report Number: 1822565-2016-01107
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00597909535
• Device Lot Number: 62900133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1